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Immubead T4 Enzyme Immunoassay Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K872192

by Immunotech Corp.

Identifiers

510(k) Number
K872192 FDA 510(k)
FDA Product Code
KLI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1700 FDA 510(k)
Regulation Number
862.1700 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Immunobead T4 Enzyme Immunoassay Kit is an Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine device, designed for the quantitative measurement of total thyroxine (T4) in serum or plasma. It employs enzyme-linked immunoassay technology to detect and quantify T4 levels, aiding in the diagnosis and monitoring of thyroid function disorders.

This kit is intended for in vitro diagnostic use in clinical chemistry laboratories. Supplied as a single-use reagent kit, it requires no special storage conditions beyond refrigeration and is classified under FDA regulation 862.1700. The device received FDA 510(k) clearance (K872192) under the Substantially Equivalent decision pathway, with a product code of KLI. No MRI safety or reusable components are specified.

Frequently asked questions

What is the Immunobead T4 Enzyme Immunoassay Kit used for in clinical practice?

This kit is designed for the quantitative measurement of total thyroxine (T4) in serum or plasma using enzyme-linked immunoassay technology. It aids clinicians in diagnosing and monitoring thyroid function disorders by providing precise T4 level readings, which are critical for managing conditions like hypothyroidism or hyperthyroidism.

Is the Immunobead T4 Enzyme Immunoassay Kit single-use or reusable, and how should it be stored?

The kit is supplied as a single-use reagent kit, meaning each kit is intended for one-time use only. Storage is straightforward—no special conditions are required beyond refrigeration, ensuring stability and reliability for its intended use in clinical chemistry laboratories.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

The kit received FDA 510(k) clearance under the *Substantially Equivalent* decision pathway, meaning it was determined to have the same intended use, technological characteristics, and performance as a legally marketed device. This clearance confirms its compliance with FDA standards for in vitro diagnostic use, specifically for measuring total thyroxine in clinical settings.

Are there any special handling requirements for this kit, such as sterility or compatibility with MRI?

The kit does not specify reusable components or MRI safety concerns, so no special handling for MRI compatibility is required. While the data does not explicitly state sterility beyond standard in vitro diagnostic practices, its classification as a single-use reagent kit implies it is intended for sterile use in controlled laboratory environments to prevent contamination.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: IMMUBEAD T4 ENZYME IMMUNOASSAY KIT - Innolitics, IMMUBEAD T4 ENZYME IMMUNOASSAY KIT 510(k) K872192 - FDA.report, PDF K872192 - Immubead T4 Enzyme Immunoassay Kit, Immunotech Corp. - 37 FDA 510 (k) Cleared Devices (Since 1980)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Immunotech Corp.

Sources (1)

  • FDA 510(k) K872192 24 fields · synced Sep 19, 2026